Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Remdesivir for Injection 100mg Lyophilized Powder: a single loading dose of 200 mg infused intravenously over 30 to 120 minutes on Day 1 followed by once-daily maintenance doses of 100
Sponsors
Jubilant Generics Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age -18 years and above (no upper age limit) 2. Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection. 3. Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 4. Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs. 2. Inability of subject or legally authorized representative to provide written informed consent. 3. Patients with 4. eGFR less than 30 mL per minute 5. Pregnant or nursing women 6. Patients with ALT/AST >= 5 times the upper limit of normal at baseline 7. Evidence of multiorgan failure 8. Mechanically ventilated (including Veno-Venous ECMO) >= 5 days, or any duration of Veno-Arterial ECMO 9. Exposed to other investigational drugs within 30 day of first administration of Remdesivir. 10. Unsuitable for the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to recovery [ Time Frame: Day 1 through Day 28] 2.Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. 3.Percentage of subjects with improvement of at least 2 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28] 4.Mortality rate at Day 28Timepoint: 28 days of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects with improvement of at least 1 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28] 2. Proportion of subjects with viral clearance (SARS CoV-2 negativity) at Day 7 and Day 14 or at hospital discharge (whichever is earlier) 3. Incidence of laboratory adverse events 4. Incidence of clinical adverse events 5. Incidence of serious adverse events (SAEs)Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed